ACTIVE INGREDIENT:
Benzocaine.....................20% in an aqueous base.
INACTIVE INGREDIENTS:
Glycerin, Polyethylene Glycol, Benzethonium Chloride, Purified Water.
DESCRIPTION:
Benzocaine, a local anesthetic, is chemically, ethyl p-aminobenzoate, C9H11NO2, with a molecular weight of 165.19.
CLINICAL PHARMACOLOGY:
Benzocaine acts by blocking conduction in nerve fibers as a result of decreased nerve cell membrane permeability to sodium ions or competition with calcium ions for membrane binding sites.
INDICATIONS AND USAGE:
RE Benzotic Otic Drops may be used as a topical anesthetic in the external auditory canal to relieve ear pain. It may be used in the treatment of acute otitis media, acute swimmer’s ear and other forms of otitis externa.
CONTRAINDICATIONS:
RE Benzotic Otic Drops is contraindicated in patients sensitive to benzocaine. This medication should not be applied in the external auditory canal if there is a perforated eardrum or ear discharge.
WARNINGS:
KEEP OUT OF REACH OF CHILDREN. NOT FOR OPHTHALMIC OR ORAL USE.
Use of anesthetic ear drops indiscriminately may mask symptoms of infection of the middle ear.
PRECAUTIONS:
General: Medication should be discontinued if sensitivity or irritation occurs.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies of animals or humans to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.
Pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This product should only be given to pregnant women if clearly needed.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Caution should be used when administered to nursing women.
Pediatric Use: Do not use in infants under 1 year of age.
ADVERSE REACTIONS:
Benzocaine can cause a hypersensitvity reaction consisting of rash, urticaria and edema. Individuals frequently exposed to ester-type local anesthetics can develop contact dermatitis characterized by erythema and pruritus. Rarely, benzocaine may induce methemoglobinemia causing respiratory distress and cyanosis which can be treated by intravenous methylene blue.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
OVERDOSAGE:
Effects of benzocaine overdosage may include yawning, restlessness, excitement, nausea and vomiting. Treatment is symptomatic. Please call your local Poison Control Center or your doctor if you suspect an overdosage of this product.
DOSAGE AND ADMINISTRATION:
Administer 4-5 drops of RE Benzotic Otic Drops in the external ear canal and then insert a cotton pledget into the meatus. Can be repeated every 1 to 2 hours, if necessary.
STORAGE:
Store at 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature]. Store in a tight, light-resistant container. [See USP.] Keep bottle tightly closed.
HOW SUPPLIED:
RE Benzotic Otic Drops are supplied as a pale yellow liquid in a 15 mL vial, NDC 68032-378-15, and include a wrapped dropper.
PACKAGING:
| RE BENZOTIC benzocaine liquid | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 02/01/2009 | 08/31/2012 | |
| Labeler - River's Edge Pharmaceuticals, LLC (133879135) |
More RE Benzotic Otic Drops resources
- RE Benzotic Otic Drops Side Effects (in more detail)
- RE Benzotic Otic Drops Use in Pregnancy & Breastfeeding
- RE Benzotic Otic Drops Support Group
- 0 Reviews for RE Benzotic Otic - Add your own review/rating
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